Use of CoG by Patients With Diabetes Mellitus
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/17/2019 |
| Start Date: | July 16, 2018 |
| End Date: | March 2019 |
Evaluation of the CNOGA TensorTip COMBO GLUCOMETER (CoG) During Standardized Meal Test and Consecutive Home Use by Patients With Diabetes Mellitus
The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose
teststrips and requiering a capillary blood sample obtained from a fingerstick and in
addition, a non-invasive optical component for prediction of tissue glucose at the fingertip.
In this study, participants will use both devices during meal tests and also at home during
routine care. The results from the device will be compared to a standard reference method and
will be used to determine the accuracy of the two device components.
teststrips and requiering a capillary blood sample obtained from a fingerstick and in
addition, a non-invasive optical component for prediction of tissue glucose at the fingertip.
In this study, participants will use both devices during meal tests and also at home during
routine care. The results from the device will be compared to a standard reference method and
will be used to determine the accuracy of the two device components.
The trial starts with a screening and training visit (V1). This is followed by an individual
calibration period for the non-invasive device component by means of multiple parallel
measurements with the invasive and the noninvasive device component. This will be done by the
participants at home. Thereafter, the participants will come to the study site and will
ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical
safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary
blood samples for comparator readings with the two CoG components and with a laboratory
reference method (YSI gucose analyzer). The patients will now continue to use the devices at
home for three months, but are not allowed to use any CoG result for treatment decisions. In
an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety
parameters and three comparison measurements will be made with the CoG device components and
the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of
the first meal test visit (V2) will be repeated, which conludes that study. In addition, the
participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.
calibration period for the non-invasive device component by means of multiple parallel
measurements with the invasive and the noninvasive device component. This will be done by the
participants at home. Thereafter, the participants will come to the study site and will
ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical
safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary
blood samples for comparator readings with the two CoG components and with a laboratory
reference method (YSI gucose analyzer). The patients will now continue to use the devices at
home for three months, but are not allowed to use any CoG result for treatment decisions. In
an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety
parameters and three comparison measurements will be made with the CoG device components and
the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of
the first meal test visit (V2) will be repeated, which conludes that study. In addition, the
participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.
Inclusion Criteria:
- Patients with Type 1 or Type 2 diabetes of Afro-American, Hispanic, or Asian-American
origin
- Subjects who are able to provide informed consent (by him/herself or by his/her
guardian);
- 18 years old and above;
- HbA1c < 10 %
- Anatomically suitable finger as determined by the clinical investigator and detailed
in section 4
Exclusion Criteria:
- Does not meet inclusion criteria;
- Subjects requiring dialysis;
- Any conditions that may hamper good visual contact between the finger and sensor, such
as raised birthmarks, scars and/or tattoos;
- Pregnancy;
- Nursing mothers;
- Any skin injuries on the measured finger;
- Severe disease conditions (cancer etc.)
- Any condition that may prevent patients from successful participation in the trial (in
discretion of the investigator)
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